You are here: Industry Insights > Roxadustat

News List

Nanjing Chiatai Tianqing Roxadustat Generic Drug Applied for Production Yi/PharmaSources
May 29, 2023
In May 2023, the CDE announced the acceptance of eight generic drug marketing applications for Roxadustat from: Nanjing Chiatai Tianqing, Wanbangde Pharmaceutical, Shanxiang Pharmaceutical, Chengdu Brilliant.
A Brief Discussion on Roxadustat in the Midst of the Controversy zhulikou431
August 31, 2021
Recently, there is a good news for roxadustat, which is in the midst of the controversy. On August 19, 2021 local time, Astellas Pharma Inc. and FibroGen jointly announced that roxadustat was approved by the European Commission (EC) for adult patients.
US rejects AZ and FibroGen’s anaemia drug roxadustat pharmatimes
August 13, 2021
The US Food and Drug Administration (US) has handed AstraZeneca a complete response letter (CRL) regarding its anaemia drug roxadustat.
Update on US Regulatory Review of Roxadustat in Anaemia of Chronic Kidney Disease americanpharmaceuticalreview
August 12, 2021
The US FDA has issued a complete response letter (CRL) regarding the New Drug Application (NDA) for roxadustat for the treatment of anemia of chronic kidney disease (CKD), in both non-dialysis dependent (NDD) and dialysis-dependent (DD) adult patients.
Status on FDA Advisory Committee Vote on Roxadustat in Anemia of Chronic Kidney Disease drugs
July 20, 2021
FDA Cardiovascular and Renal Drugs Advisory Committee (CRDAC) has voted 13 to 1 that the benefit-risk profile of roxadustat does not support approval for the treatment of anemia in chronic kidney disease (CKD) in NDD adult patients.
FDA Vote on Roxadustat in Anemia of Chronic Kidney Disease americanpharmaceuticalreview
July 19, 2021
The FDA Cardiovascular and Renal Drugs Advisory Committee (CRDAC) has voted 13 to 1 that the benefit-risk profile of roxadustat does not support approval for the treatment of anemia in chronic kidney disease (CKD) in non-dialysis dependent (NDD) adult ...
AstraZeneca and FibroGen's roxadustat, not yet filed in U.S., nabs 2nd anemia nod in China fiercepharma
August 25, 2019
FibroGen has not even filed its AstraZeneca-partnered oral anemia drug roxadustat for U.S. approval. But the collaborators have already scored their second nod for the blockbuster hopeful in China.
Roxadustat Noninferior to Epoetin Alfa in Dialysis Patients drugs
July 29, 2019
Roxadustat is noninferior to epoetin alfa for increasing hemoglobin levels among patients with anemia who are undergoing dialysis, and is superior to placebo for patients not undergoing dialysis...
AstraZeneca’s roxadustat reveals positive results against anaemia biospectrumasia
July 28, 2019
AstraZeneca and FibroGen China, a wholly-owned subsidiary of FibroGen Inc., are collaborating on the development and commercialisation of roxadustat in China
Pooled Analyses of the Roxadustat Global Phase III Programme Confirmed Cardiovascular Safety drugs
May 20, 2019
Pooled Analyses of the Roxadustat Global Phase III Programme Confirmed Cardiovascular Safety.

Previous page 1 2 Next page